Zimmer Biomet Recalls Sterile Intramedullary Nail Implants Due to Packaging Failures
Zimmer Biomet is recalling sterile intramedullary nail implants and accessories because packaging design verification tests failed.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the source text does not report any illnesses, injuries, or hospitalizations. The hazard is related to packaging verification failures, which is a precautionary measure without confirmed harm, fitting the Moderate criteria for low-risk contamination or voluntary precautionary recalls.
Plain-English summary
Zimmer Biomet, Inc. initiated a field action on February 28, 2017, for sterile-packaged implants. The specific products involved are the Fem IM Nail 15mmdx50cm, sterile rod fixation intramedullary implants, and specific knee, hip, and nail implant accessories. The recall covers 9,867 units.
The reason for the field action is that the sterile packaging design failed verification tests. The source text does not specify the exact nature of the failure or whether sterility was compromised, but the action was taken due to these test failures.
The affected products were distributed worldwide, including in the United States and numerous foreign countries such as Argentina, Australia, Belgium, Brazil, Canada, and others. The affected items are identified by Item Number 00225250015 and have an expiry date before March 2027. Healthcare providers and facilities should check their inventory for these specific item numbers and stop using them if they match the description.
The recalled product
- Product
- Fem IM Nail 15mmdx50cm, Sterile, Rod, fixation, intramedullary and accessories- Specific Knee, Hip and Nail Implants
- Manufacturer
- Zimmer Biomet, Inc.
- Affected units
- 9,867
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Item Number:00225250015
- Lot Number Expiry Date Before: March 2027
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 35 recalled by Zimmer Biomet, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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